the parallel study to evaluate the pharmacokinetics, pharmacodynamics, and safety of ckd-843 a

Conditions: Alopecia

Summary: a study to evaluate the pharmacokinetics, pharmacodynamics, and safety of ckd-843 a in male subjects.


Eligibility criteria:
inclusion criteria: * those who aged between 19 to 50 * (part 1) those who are diagnosed to androgenic alopecia and meet criteria basp grade * m2\~m3 or c2\~c3 grade with v1\~v3 or f1\~f3 * m1 or c1 grade with v2\~v3 or f2\~f3 * (part 1) those who consent to the condition write below * scalp tattoo \& to cutting hair for hair evaluation * maintaining hair style \& color * (part 2) those who are healthy male (regardless of alopecia) * those who has body weight ≥ 55kg * those who has calculated body mass index(bmi) of 18.5 ≤ \~ \< 27.0 kg/m2 * body mass index, kg/m2= body weight(kg)/\[height(m)2\] * those who consent to proper contraception and do not donate sperm until 6 months after the last administration of investigational product * those who understanding the detailed description of this clinical trial and voluntarily decide to participate exclusion criteria: * those who have clinically significant disease or medical history of hepatopathy, renal dysfunction, neurological disorder, immunity disorder, respiratory disorder, genitourinary system disorder, hemato-oncology disorder, cardiovascular disorder or psychical disorder * (part 1) those who meets the conditions write below * alopecia areata, telogen alopecia * those who has psoriasis or folliculitis or scar on hair evaluation area * those who has experience of platelet-enriched plasma treatment to scarp within 24 weeks before the first administration of investigational product * those who has experience of light or laser treatment to scarp within 12 weeks before the first administration of investigational product * those who has experience of prophylaxis or medication of hair loss within 14 days before the first administration of investigational product * those who take dutasteride or finasteride within 6 month before the first administration of investigational product * those who has hypersensitivity to dutasteride or other 5-alpha reductase related inhibitors. * (part 1) those who has hypersensitivity to tatto ink. * those who have the screening(d-28\~d-2) test results write below * ast, alt \> 1.5 times higher than upper normal level * total bilirubin \> 1.5 times higher than upper normal level * egfr (estimated glomerular filtration rate, which is calculated by mdrd) \< 60 ml/min/1.73m2 * "positive" or "reactive" test result of hepatitis b \& c, hiv, rpr * under 5 min resting condition, systolic blood pressure \>150 mmhg or \ 100 mmhg or \<50 mmhg * those who has a drug abuse history within one year or positive reaction on urine drug screening test. * those who receive following drugs, which may affect results of clinical trial and safety ethical-the-counter (etc) drugs and herbal medicines within 14 days before the first administration and over-the-counter (otc) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product. * those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 30 days before the first administration of investigational product. * those who exceeding smoke \& alcohol consumption criteria. * smoke: \> 10 cigarettes/day * caffeine: \> 5 cups/day * alcohol \> 210 g/week * those who take grapefruit within 7 days before the first administration of investigational product. * those who receive investigational product by participating in other clinical trial within 180 days before the first administration of investigational product. * those who donate whole blood within 60 days or apheresis within 30 days before the first administration of investigational product. * those who receive transfusion within 30 days before the first administration of investigational product. * those who are deemed inappropriate to participate in clinical trial by investigators.